The Daily Biotech Pulse: Roche's Lung Cancer Combo Therapy Flunks Late-Stage Study, Adagio Spikes On Positive COVID Antibody Data, Amylyx Awaits Adcom Verdict

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

J&J, ViiV Co-developed Long-Acting HIV Treatment Gets FDA Approval For Treating Adolescents

Johnson & Johnson's JNJ Janssen unit said the U.S. Food and Drug Administration has approved Cabenuva (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents, who are 12 years of age or older, weigh at least 35 kg and are on a stable antiretroviral regimen, with no history of treatment failure, nor known or suspected resistance to either cabotegravir or rilpivirine.

Cabenuva has been co-developed as part of a collaboration with ViiV Healthcare, and it's the first to be made available for eligible adolescents. ViiV is a HIV joint venture floated by Pfizer, Inc. PFE and (GlaxoSmithKline plc GSK, with participation also from Japan's Shionogi & Co., Ltd. SGIOY.

Roche's Late-Stage Study Of Triple Combo Therapy In Lung Cancer Fails To Meet Co-Primary Endpoint

Roche Holding AG's RHHBY Genentech unit announced the Phase 3 SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq and chemotherapy as an initial treatment for people with extensive-stage small cell lung cancer did not meet its co-primary endpoint of progression-free survival.

The co-primary endpoint of overall survival was not met in its interim analysis and is unlikely to reach statistical significance in the planned final analysis. Data suggest tiragolumab plus Tecentriq and chemotherapy was well-tolerated and no new safety signals were identified when adding tiragolumab.

Click here to access Benzinga's FDA Calendar

Adagio's Antibody Treatment Found Effective For Preventing And Treating COVID-19

Adagio Therapeuticals, Inc. ADGI said the primary endpoints were met with statistical significance for all three indications in the company's ongoing global Phase 2/3 clinical trials evaluating its investigational drug adintrevimab as a pre-and-post-exposure prophylaxis and treatment for COVID-19. The company said it plans to engage with the FDA and to submit an emergency use authorization application in the second quarter for adintrevimab for both the prevention and treatment of COVID-19.

The stock was jumping 44.58% to $5.59 in premarket trading.

Sonoma Announces Availability Of Urinary Tract Infection Products In New Zealand, Australia And South Africa

Sonoma Pharmaceuticals, Inc. SNOA announced the launch of Microdox, an urinary tract infection catheter and bladder rinse in New Zealand, Australia and South Africa.

The stock was rising 10.42% to $3.71 in premarket trading.

Offerings

Geron Corporation GERN said it intends to offer and sell shares of its common stock, or for certain investors that so choose, pre-funded warrants to purchase shares of its common stock, together with accompanying warrants to purchase shares of its common stock in an underwritten public offering.

The stock was slipping 19.53% to $1.03 in premarket trading.

IGM Biosciences, Inc. IGMS priced its underwritten public offering of 8.696 million shares of its non-voting common stock at a price to the public of $23 per share. IGM expects to receive total gross proceeds of approximately $200 million from this offering. All of the shares in the offering will be sold by IGM.

The company announced Tuesday a collaboration with Sanofi SNY to develop antibody treatments against cancer and immunological/inflammatory diseases.

The stock was slipping 8.34% to $27.03 in premarket trading.

Calithera Biosciences, Inc. CALA priced its previously announced underwritten public offering of 18.52 million shares of its common stock at a price of 54 cents per share.

Each share is accompanied by a warrant to purchase one share at an exercise price of 54 cents per share, which is immediately exercisable and will expire 18 months from the date of issuance, or a short-term warrant, and a warrant to purchase one share an exercise price of 54 cents per share, which is immediately exercisable and will expire 5 years from the date of issuance, or a long-term warrant.

The gross proceeds to Calithera from the offering are expected to be approximately $10 million. All of the shares of common stock and warrants are being offered by Calithera.

The stock was plunging 26.43% to 43.97 cents in premarket trading.

Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures

On The Radar

Adcom Calendar

FDA's Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to meet Wednesday to discuss Amylyx Pharmaceuticals, Inc.'s AMLX NDA for sodium phenylbutyrate/taurursodiol powder for oral suspension, for the treatment of amyotrophic lateral sclerosis. The stock came under selling pressure on Monday following the release of the briefing documents, which reflected skepticism among FDA staffers regarding the drug.

Clinical Readouts/Presentations

Replimune Group, Inc. REPL is due to present at its virtual investor event updated data from the completed cohorts of the Phase 2 clinical trial of RP1 in non-melanoma skin cancer and melanoma. Additionally, the company will also present new data from the ongoing clinical trial in anti-PD1 failed NMSC and from the Phase 1b/2 clinical trial of RP1 as monotherapy in solid organ transplant recipients with skin cancer.

Earnings

Taysha Gene Therapies, Inc. TSHA (before the market open)
PDS Biotechnology Corporation PDSB (before the market open)
Affimed N.V. AFMD (before the market open)
Adamis Pharmaceuticals Corporation ADMP) (after the close)
INVO Bioscience, Inc. INVO) (after the close)
Calithera Biosciences, Inc. CALA (after the close)
Inhibikase Therapeutics, Inc. IKT (after the close)
Spero Therapeutics, Inc. SPRO (after the close)
Biocept, Inc. BIOC