Axsome Therapeutics (AXSM) : disappointing regulatory update for AXS-05

 Disappointing regulatory update for AXS-05 as a potential treatment for major depressive disorder (MDD).  

• Specifically, Axsome revealed during its 2021 second-quarter earnings release this morning that the U.S. Food and Drug Administration (FDA) had notified the company on July 30, 2021 that it has identified deficiencies within the drug's regulatory application that preclude discussion of labeling and post-marketing requirements at this time. A final decision on AXS-05's regulatory review for MDD is currently slated for Aug. 22, 2021.

  

 

 

The company announced that AXS-05 met the primary and key secondary endpoints in the Phase 2 MERIT trial and "substantially and statistically significantly prevented relapse of depressive symptoms compared to placebo in patients with treatment resistant depression." Co further stated, among various business updates, that as part of the ongoing review of its NDA for AXS-05, the FDA recently notified co that it has identified deficiencies that preclude labeling discussions at this time; the development may lead to a delay in the potential approval of AXS-05. Co also reported Q2 results. At 52-week lows.

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New York, NY-based Axsome Therapeutics (NASDAQ:AXSM) had its IPO on Nov 20, 2015 IPO. The stock opened at $9.00 on its first day of trading.

The clinical stage biopharmaceutical firm develops therapies for the management of pain and disorders of the central nervous system (CNS). Its lead product candidate is Phase 3-stage AXS-02 (disodium zoledronate tetrahydrate), a non-opioid therapeutic for chronic pain. The company is targeting three specific areas for development: complex regional pain syndrome, osteoarthritis of the knee associated with bone marrow lesions and chronic low back pain associated with Modic changes (changes in bones of the spine). Its second candidate is Phase 3-stage AXS-05, a fixed dose of combination of dextromethorphan and bupropion, for treatment-resistant depression and Alzheimer's disease-associated agitation.

Alset EHome (AEI) Prices Public Offering of Shares, Warrants

 

Alset EHome International Inc. said it has priced an underwritten public offering of 6.4 million common shares to be issued by the company at $2.12 a share.

 

 The holding company also is issuing pre-funded warrants to purchase 8.7 million shares at $2.11 per pre-funded warrant. The pre-funded warrants have an exercise price of one cent a share.

The proceeds from the offering, are expected to be $32 million.

Alset EHome granted the underwriters a 45-day option to purchase additional shares, representing up to 15% of the number of the shares and pre-funded warrants sold in the base offering, solely to cover over-allotments, if any.

Cara Therapeutics (CARA) : Korsuva fails for the treatment in atopic dermatitis (AD) patients

   

 

 

  

 

 

 

 

Cara Therapeutics announces topline results from its KARE Phase 2 dose-ranging clinical trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis patients

Study did not meet Primary Endpoint of worst-itch NRS change from baseline at week 12 or Secondary Endpoint of 4-point responder analysis in the ITT patient population.

Study achieved Primary Endpoint of worst-itch NRS change and Secondary Endpoint of 4-point responder analysis in pre-specified analyses of mild-to-moderate AD patients (64% of ITT patient population).

Statistically significant improvement in 4-point responder analysis in mild-to-moderate (BSA <10%) AD patients with 32% of KORSUVA-treated patients achieving a > 4-point reduction vs. 19% in placebo group (p=0.03).

KORSUVA was well tolerated at all dose levels.

GRPN : downgraded to sell from neutral at Goldman

Ticker: GRPN

 

-=ResTORbio (TORC) : late-stage drug failure

• Announced that top line data from the PROTECTOR 1 Phase 3 study did not meet its primary endpoint and that it has stopped the development of RTB101 in this indication.

ResTORbio (Nasdaq:TORC) disclosed Friday that its drug for potentially deadly respiratory tract infections did not meet its primary goal in a Phase 3 trial. Despite showing promise in earlier testing, the drug ultimately failed to decrease respiratory illnesses in subjects 65 years or older.

The drug, called RTB101, is resTORbio’s only clinical stage drug candidate. The 21-person company plans to continue developing the drug for use against Parkinson’s disease — a plan some analysts are skeptical will be fruitful.

“We regard the evidence of benefit or effect in the new Parkinson’s disease indication as very marginal, and given the complex biology of this disease, and the lack of understanding of the disease process, find it hard to give the company any credit for this indication,” SVB Leerink analyst Geoff Porges wrote in an analyst note Friday.

The company emerged out of life sciences incubator and investment firm PureTech Health with plans to tackle aging-related diseases. PureTech still owns a 27 percent stake in resTORbio, according to the company’s website.

ResTORbio has $117 million in cash and liquidatable investments, which executives estimate will support the company through 2020. The company expects to release data from its mid-stage Parkinson’s trial in mid-2020.

-==AnaptysBio (ANAB) : Etokimab ATLAS Phase 2b fails to meet primary endpoint

AnaptysBio misses by $0.06; Etokimab ATLAS Phase 2b fails to meet primary endpoint 

Reports Q3 (Sep) loss of $1.15 per share, $0.06 worse than the S&P Capital IQ Consensus of ($1.09).

Etokimab (ANB020 Anti-IL-33) Program

• The Company today announced topline data from its ATLAS trial, a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in approximately 300 adult patients treated with etokimab in moderate-to-severe atopic dermatitis. Each of the etokimab dosing arms failed to meet the primary endpoint of the trial, which was demonstration of statistically greater improvement in the Eczema Area and Severity Index (EASI) relative placebo at week 16.
• AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. The Company anticipates topline data from an interim analysis of the ECLIPSE trial in the first quarter of 2020.
• The Company has decided to postpone the initiation of its planned Phase 2b etokimab clinical trial in eosinophilic asthma, a multi-dose, randomized, double-blinded, placebo-controlled trial in 300-400 patients, until it has the opportunity to analyze the full data set from the ATLAS trial.

"While we are disappointed with the top-line results of our etokimab ATLAS trial, we intend to re-evaluate our etokimab development strategy following additional data from ATLAS and top-line results from ECLIPSE in the first quarter of 2020," said Hamza Suria, president and chief executive officer of AnaptysBio. "We look forward to advancing ANB019, ANB030 and additional preclinical programs in our wholly-owned pipeline."

AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan, taking into account the adjustments to etokimab clinical development activities referenced above, at least into 2021. The Company expects to re-evaluate its current operating plan in light of the topline data from the ATLAS trial and to make adjustments as appropriate to manage the Company's available cash resources.

Tocagen (TOCA) : late-stage trial of cancer treatment misses primary endpoint

** charts after earnings **

Shares of Tocagen Inc. plummeted 82% on heavy volume toward a record low Thursday, after the gene company said a late-stage trial of its brain cancer treatment failed to meet its primary endpoint of survival compared with standard of care treatment. Trading volume of 975,000 shares ahead of the open was already more than triple the full-day average of about 253,000 shares. The company said all secondary endpoints of the phase 3 trial evaluating Toca 511 and Toca FC in patients with recurrent high grade glioma undergoing resection showed no meaningful difference between the arms of the trial. The company said further analysis of the trial data is underway. The stock is on track to open below the $1 mark, below the previous record low close of $3.00. It had already tumbled 49.1% year to date through Wednesday.

Domo (DOMO) reported earnings on Thur 5 Sept 19 (a/h)

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Domo beats by $0.03, reports revs in-line; guides Q3 EPS below consensus, revs below consensus; guides FY20 EPS below consensus, revs below consensus

Reports Q2 (Jul) loss of $0.96 per share, $0.03 better than the S&P Capital IQ Consensus of ($0.99); revenues rose 21.6% year/year to $41.7 mln vs the $41.68 mln S&P Capital IQ Consensus.

Subscription revenue was $34.9 mln, an increase of 24% yr/yr.

Billings were $38.8 mln, or 9% yr/yr growth.

Co issues downside guidance for Q3, sees EPS of ($1.04)-($1.00) vs. ($0.91) S&P Capital IQ Consensus; sees Q3 revs of $41.5-$42.5 vs. $44.25 mln S&P Capital IQ Consensus.

Co issues downside guidance for FY20, sees EPS of ($4.10)-($4.00) vs. ($3.82) S&P Capital IQ Consensus; sees FY20 revs of $168-$169 mln vs. $173.57 mln S&P Capital IQ Consensus.

Aptevo Therapeutics (APVO) : pricing of equity offering

 

Aptevo Therapeutics (APVO) slumps on almost 13x higher volume in response to its public offering of 19.85M shares of common stock and warrants to purchase up to the same number of shares at a price of $1.00 per share and warrant.

• The company is also offering pre-funded warrants to purchase up to 2.15M common shares at $0.01 per share and related warrants to purchase up to 2.15M common shares at $1.30 at a combined price of $0.99.
• Total gross proceeds should be ~$22.00M. Closing date is March 11.
• Yesterday's close was $1.48.

G1 Therapeutics (GTHX) : placebo beats drug in cancer response rate test

G1 Therapeutics’ cancer drug trilaciclib has failed to beat placebo against multiple efficacy measures in phase 2. Trilaciclib performed well against its neutropenia-related primary endpoints but fell short in terms of response rate, prompting investors to send G1's stock down 26%.

   

death cross

North Carolina-based G1 designed the phase 2 to assess whether short-acting intravenous CDK4/6 inhibitor trilaciclib could reduce the occurrence and duration of Grade 4 neutropenia—a condition defined by abnormally low levels of a type of white blood cell—in patients with second or third-line small cell lung cancer (SCLC). The trial hit its primary endpoints by showing that trilaciclib, when added to chemotherapy drug topotecan, is more effective than placebo at controlling neutropenia.

That primary endpoint success enabled G1 to paint the results as positive. However, investors looked past the neutropenia data and zeroed in on a line deep in G1’s statement about rates of objective responses and clinical benefit seen in the trial, as well as the progression-free survival.

Of the 26 patients in the placebo arm, six responded, resulting in an objective response rate (ORR) of 23.1%. In the trilaciclib arm, four of the 30 patients responded, giving an ORR of 13.3%. The clinical benefit rate and progression-free survival were almost identical across the two arms, coming in at around 60% and 4.2 months, respectively.

G1 thinks trilaciclib may improve overall survival (OS) by preserving immune system function during chemotherapy. But G1 is yet to generate the mature OS data needed to validate that idea, and trilaciclib’s performance against other measures of efficacy has been mixed. A metastatic triple-negative breast cancer trial recently linked use of trilaciclib to improved ORR, but an earlier study in first-line SCLC found it was numerically worse than placebo against the objective response yardstick.

Despite that, G1 Chief Medical Officer Raj Malik thinks the biotech has emerged from the midphase program with data to support the advance of trilaciclib.

“We now have four randomized phase 2 trials showing trilaciclib’s multi-lineage myelopreservation benefits. We plan to meet with U.S. and European regulatory authorities in 2019 to discuss the totality of trilaciclib data and pathways to approval,” Malik said in a statement.

Inspire Medical Systems (INSP) prices 2.5 mln shares at $40.00 per share

• Inspire Medical Systems announces pricing of previously announced offering of 2.5 mln shares of its common stock at a public offering price of $40.00 per share

 

Gogo Inc.(GOGO) : Moody's lowers the company's credit ratings

• ticker:  GOGO

** charts after downgrade **  

 

Moody's lowered the company's credit ratings across the board.

In a research note published after the closing bell on Monday, Moody's lowered Gogo's corporate credit rating and probability-of-default grade from B3 to Caa1. The speculative grade liquidity rating fell from SGL-2 to SGL-3.

Moody's view of Gogo moved from "highly speculative" to "substantial risks," with a negative outlook that could lead to even further rating cuts in the near term.

GlycoMimetics (GLYC) reported earnings on Tue 6 March 2018 (b/o)

• Also announces its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC Mitoxantrone, etoposide and Ara-C or in combination with fludarabine, cytosine arabinoside and idarubicin in individuals with relapsed/refractory acute myeloid leukemia

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GlycoMimetics misses by $0.02 

• Reports Q4 EPS of ($0.27) vs ($0.25) Capital IQ consensus; co reported no revs (as expected)
• Cash position: As of December 31, 2017, GlycoMimetics had cash and cash equivalents of $123.9 million as compared to $40.0 million as of December 31, 2016.
• Operations - In the Phase 3 trial of rivipansel, being conducted by our collaborator Pfizer, investigators are evaluating patients hospitalized for vaso-occlusive crisis of sickle cell disease. Pfizer reports that the study remains on track for completion in the second half of 2018.

GlycoMimetics announces its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC Mitoxantrone, etoposide and Ara-C or in combination with fludarabine, cytosine arabinoside and idarubicin in individuals with relapsed/refractory acute myeloid leukemia

• The design is aligned with guidance received from the FDA.
• The single pivotal trial is planned to enroll 380 adult patients worldwide and is expected to begin in the third quarter of 2018. The primary endpoint will be overall survival, and censoring for transplant in the primary efficacy analysis will not be required.
• Key secondary endpoints will include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling, if GMI-1271 is approved by the FDA. In 2017, GMI-1271 received Breakthrough Therapy Designation.
• "Reaching alignment with the FDA on overall survival as the primary endpoint for the trial, without statistical censoring for transplant, positions GMI-1271 well for a potential successful outcome," said Rachel King, Chief Executive Officer of GlycoMimetics. "Getting more patients to transplant following treatment with GMI-1271 is one of our goals for this therapy. If we accomplish this, we hope GMI-1271 will contribute to prolonged overall survival for relapsed/refractory AML patients. We believe this is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of this patient population. In addition, we believe that our trial design should streamline the path to data on overall survival, considered the 'gold standard' of clinical benefit, and that if this primary endpoint is achieved, it should position GMI-1271 optimally with U.S. and European regulatory agencies, as well as in the marketplace."