The Daily Biotech Pulse: Roche Gets Authorization For COVID-19 Treatment, Nods For Sanofi-Regeneron In Europe, Osmotica Divestment, 2 IPOs

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 24)

• AngioDynamics, Inc. ANGO
• Apellis Pharmaceuticals, Inc. APLS
• Atossa Therapeutics, Inc. ATOS
• Axonics, Inc. AXNX
• Catalyst Pharmaceuticals, Inc. CPRX
• Celcuity Inc. CELC
• Cortexyme, Inc. CRTX
• Dicerna Pharmaceuticals, Inc. DRNA
• Edwards Lifesciences Corporation EW
• Eli Lilly and Company LLY (announced intention to file regulatory application for Alzheimer's disease drug later this year)
• Intuitive Surgical, Inc. ISRG
• Lantheus Holdings, Inc. LNTH
• NovoCure Limited NVCR
• OrthoPediatrics Corp. KIDS
• ResMed Inc. RMD
• ShockWave Medical, Inc. SWAV
• Vericel Corporation VCEL
• West Pharmaceutical Services, Inc. WST
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 24)

• 4D Molecular Therapeutics, Inc. FDMT (reacted to Roche Holding AG RHHBY terminating a licensing deal)
• Achilles Therapeutics plc ACHL
• Galapagos NV GLPG
• Impel NeuroPharma, Inc. IMPL
• Medicenna Therapeutics Corp. MDNA
• Terns Pharmaceuticals, Inc. TERN
• VectivBio Holding AG VECT (announced receipt of orphan drug designation for apraglutide for the prevention of acute graft-versus-host disease)

Stocks In Focus

Mirati's KRAS Inhibitor Adagrasib Gets Breakthrough Designation For Lung Cancer Treatment

Mirati Therapeutics, Inc. MRTX said the FDA has granted breakthrough therapy designation to adagrasib for the potential treatment of patients with non-small cell lung cancer, who harbor the KRASG12C mutation following prior systemic therapy.

The stock was up 3.72% at $168.50 in premarket trading.

Roche's Rheumatoid Arthritis Drug Authorized For Emergency Use In Hospitalized COVID Patients

Roche Holding AG RHHBY said the FDA has issued an emergency use authorization for intravenous Actemra for the treatment of COVID-19 in hospitalized adults and pediatric patients, 2 years of age and older, who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates

Bristol-Myers Squibb Gets EMA Committee Backing For Cell Therapy For Multiple Myeloma

Bristol-Myers Squibb Company BMY said the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended granting conditional marketing authorization for Abecma, its B-cell maturation antigen-directed CAR T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

Pieris to Study PRS-220 For Idiopathic Pulmonary Fibrosis and Post-COVID Pulmonary Fibrosis

Pieris Pharmaceuticals, Inc. PIRS announced the development of PRS-220 for the treatment of idiopathic pulmonary fibrosis. The company also announced it has been selected to receive a 14.2-million-euro ($17 million) grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy for the R&D of PRS-220 for post-acute sequelae of SARS-CoV-2 infection pulmonary fibrosis, also known as post-COVID-19 syndrome pulmonary fibrosis or "long COVID."

Clinical development of the program for both indications is expected to begin next year, it added.

The stock was rallying 13.96% to $4.98 in premarket trading.

Osmotica Agrees to Divest Legacy Products Portfolio and Georgia Manufacturing Facility For Up to $170M

Osmotica Pharmaceuticals, plc OSMT announced it has entered into a definitive Purchase and Sale Agreement with Alora Pharmaceuticals, pursuant to which Alora will acquire Osmotica's portfolio of legacy products and its Marietta, Georgia manufacturing facility, for up to $170 million.

The proceeds generated by the sale, according to the company, will be used to retire a substantial portion of outstanding indebtedness and position the company to accelerate the commercialization efforts of its flagship product, Upneeq.

The shares were jumping 37.32% to $3.90 in premarket trading.

Sanofi-Regeneron's Libtayo Approved In Europe For Skin Cancer and Lung Cancer With Certain Mutations

Sanofi SNY and Regeneron Pharmaceuticals, Inc. REGN said the European Commission has approved their Libtayo to treat adults with locally advanced or metastatic basal cell carcinoma who have progressed on or are intolerant to a hedgehog pathway inhibitor.

BCC is the most common type of skin cancer worldwide, representing up to 80% of non-melanoma skin cancers, and incidence is increasing across many European countries, the company said.

Additionally, the EC approved Libtayo for the first-line treatment of adults with non-small cell lung cancer. whose tumor cells have 50% or more PD-L1 expression and no EGFR, ALK or ROS1 aberrations.

Adial's Alcohol Use Disorder Drug Fails to Get Fast Track Designation From FDA

Adial Pharmaceuticals, Inc. ADIL said the FDA has rejected its request for fast track designation for its drug candidate, AD04, for the treatment of alcohol use disorder in pediatric patients and adult patients with alcoholic liver disease, with select polymorphisms of the serotonin transporter and receptor genes.

While AD04 is being developed and undergoing a pivotal Phase 3 trial to treat any adult with AUD with the targeted genetics, Adial said it believes AD04 holds the potential to effectively and safely treat AUD patients that are adolescents or have ALD.

Offerings

Theravance Biopharma, Inc. TBPH priced its underwritten public offering of 6.7 million ordinary shares at a price to the public of $15 per share.

The gross proceeds to Theravance Biopharma from the offering are expected to be $100.5 million. The offering is expected to close on June 29, subject to customary closing conditions.

The stock was slipping 9.06% at $15.55 in premarket trading.

On The Radar

PDUFA Dates

The FDA could also rule on AbbVie, Inc.'s ABBV sNDA for Rinvoq as a treatment option for patients with active ankylosing spondylitis. Given the regulatory application was accepted for regular review on Aug. 25, 2020, a decision could come by Friday.

Clinical Readouts

Vir Biotechnology, Inc. VIR is scheduled to present at the EASL International Liver Congress additional Phase 1 study evaluating the neutralizing, vaccinal monoclonal antibody VIR-3434 in participants with chronic hepatitis B virus infection.

Assembly Biosciences, Inc. ASMB will present at the EASL congress Phase 2 data for second generation hepatitis B virus core inhibitors ABI-H2158.

Also at the congress, Inventiva S.A. IVA is due to present subgroup analysis of data from the Phase 2b study of Lanifibranor therapy in patients with NASH and F2 and F3 fibrosis stages.

Regulus Therapeutics Inc. RGLS will present at the Polycystic Kidney Disease Connect Conference data from the first cohort of Phase 1b study of RGLS4326 in patients with autosomal dominant polycystic kidney disease.

IPO

Elevation Oncology, Inc., a clinical stage biopharma focused on the development of precision medicines for patients with genomically defined cancers, priced its initial public offering of 6.25 million shares of its common stock at a public offering price of $16 per share.

All of the shares are being offered by Elevation Oncology. The gross proceeds from the offering are expected to be $100 million. The shares are expected to begin trading on the Nasdaq under the ticker symbol "ELEV."

Graphite Bio, Inc., a clinical-stage gene editing company focused on therapies that harness targeted gene integration to treat or cure serious diseases, priced its upsized IPO of 14 million shares of its common stock at a price $17 per share. All of the shares of common stock are being offered by Graphite Bio.

The gross proceeds to Graphite Bio from the offering are expected to be $238.0 million. The shares are expected to begin trading on the Nasdaq Global Market on June 25, 2021 under the ticker symbol "GRPH."