The Daily Biotech Pulse: FDA Approvals For Merck, Pacira And Zealand, Roche-Regeneron Ace Late-Stage COVID-19 Study, AlloVir Appoints Gilead Virology Chief As CEO

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 March 22)

• Acceleron Pharma Inc. XLRN
• Aclaris Therapeutics, Inc. ACRS
• Affimed N.V. AFMD
• Amneal Pharmaceuticals, Inc. AMRX
• BioCryst Pharmaceuticals, Inc. BCRX (announced positive results for BCX9930 in treatment-naïve paroxysmal nocturnal hemoglobinuria)
• CTI BioPharma Corp. CTIC (reacted to a Phase 1 readout for pacritinib in preventing acute graft-versus-host disease)
• Instil Bio, Inc. TIL (went public Friday)
• MacroGenics, Inc. MGNX
• Nuvation Bio Inc. NUVB
• Oramed Pharmaceuticals Inc. ORMP (announced a pact to develop oral COVID-19 vaccine)
• Organogenesis Holdings Inc. ORGO
• Protagonist Therapeutics, Inc. PTGX
• Radius Health, Inc. RDUS
• Seneca Biopharma, Inc. SNCA
• Sesen Bio, Inc. SESN
• SI-BONE, Inc. SIBN
• Sierra Oncology, Inc. SRRA
• Theratechnologies Inc. THTX (reacted to a presentation at the Endocrine Society's annual meeting, ENDO 2021)

• Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 22)

• Adagene Inc. ADAG
• Finch Therapeutics Group, Inc. FNCH (went public Friday)
• Harmony Biosciences Holdings, Inc. HRMY
• Odonate Therapeutics, Inc. ODT (announced winding down of its lead clinical program and operations)
• Reviva Pharmaceuticals Holdings, Inc. RVPH

Stocks In Focus

Chiasma Presents Positive Long-Term Data For Acromegaly Treatment

Chiasma, Inc. CHMA presented at the ENDO 2021 meeting with positive long-term safety and efficacy data from the open-label extension study of Mycapssa in patients with acromegaly.

Mycapssa was approved by the FDA in June 2020.

The stock was up 4.65% to $3.60 in premarket trading.

Protagonist To Start Phase 3 Study Of Rusfertide In Blood Cancer

Protagonist Therapeutics said it intends to start a global Phase 3 study of rusfertide in polycythemia vera. This follows an end-of-Phase 2 meeting with the FDA and written communication received from the European Medicines Agency that was supportive of the pivotal clinical development plan in PV.

In after-hours trading, the stock gained 6.14% to $33.

Merck's Keytruda Snags Another FDA Approval

Merck MRK said the Food and Drug Administration approved Keytruda, its anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.

Roche Stops Dosing In Late-Stage Study Of In-Licensed Antisense Therapy In Huntington's Disease

Roche Holding AG RHHBY said it has decided to discontinue dosing in the Phase 3 GENERATION HD1 study of tominersen in manifest Huntington's disease. The decision was based on the results of a pre-planned review of the data from the Phase 3 study conducted by an unblinded Independent Data Monitoring Committee.

The company said it intends to continue following participants for safety and clinical outcomes without the dosing of the investigational medicine or placebo.

Tominersen is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein, and it has been licensed from Ionis Pharmaceuticals, Inc. IONS.

Ionis shares were down 19.57% premarket at $44.75. 

Allovir Hires Gilead's Virology Head As CEO

AlloVir ALVR said its board has appointed Diana Brainard as the company's chief executive officer effective May 17. Brainard has served on AlloVir's board since April 2019.

Brainard is leaving a position as SVP and head of the virology therapeutic area at Gilead Sciences, Inc GILD.

She will succeed David Hallal, who will step down as CEO and continue to serve as executive chairman of the board, the company said. 

Novartis' Radioligand Therapy Aces Late-Stage Prostate Cancer Study

Novartis AG NVS reported positive results for the the Phase 3 VISION study evaluating the efficacy and safety of Lu-PSMA-617, a targeted radioligand therapy in patients with progressive PSMA-positive, metastatic castration-resistant prostate cancer vs. the standard of care alone. The trial met both primary endpoints of overall survival and radiographic progression-free survival.

Related Link: FDA Decisions For Pfizer, Eli Lilly And Bluebird Bio, Bristol-Meyers Squibb, Plus New Data And Earnings

Roche-Regeneron's COVID-19 Antibody Cocktail Aces Late-Stage Study

Roche and Regeneron Pharmaceuticals, Inc. REGN announced positive topline results from a trial assessing a COVID-19 treatment in infected non-hospitalized patients.

The Phase 3 outcomes trial in high-risk non-hospitalized patients with COVID-19 met the primary endpoint, showing the investigational antibody cocktail of casirivimab and imdevimab reduced the risk of hospitalization or death by 70% at a 1,200 mg dose and by 71% at a 2,400 mg dose compared to a placebo.

Casirivimab and imdevimab also met all key secondary endpoints, including the ability to reduce symptom duration from 14 to 10 days.

The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants based on the recently updated emergency use authorization guidance from the FDA, the companies said.

OncoCyte, UniQure Move On Insider Transactions

OncoCyte Corporation OCX said in a filing that its CEO Ronald Asbury Andrews bought 11,000 shares for $4.7911 per share.

uniQure N.V. QURE said its CEO Matthew Kapusta sold 2,250 shares in the company.

OncoCyte shares added 6.61% to $5 in after-hours trading, while uniQure slipped 4.04% to $33.23 in after-hours trading.

BioLife To Buy Cold Storage Chain Company Stirling

BioLife Solutions, Inc. BLFS announced an agreement to acquire Stirling Ultracold, a privately held innovative developer and manufacturer of ultra-low temperature freezers. The deal is expected to close early in the second quarter.

"Combining Stirling's -20°C to -86°C freezer systems with our liquid nitrogen products provides complete ultra-low temperature cold-chain infrastructure critical for personalized medicine," BioLife's CEO Mike Rice said.

Separately, BioLife Solutions reported fourth-quarter results showing a 78% year-over-year increase in revenues to $14.7 million. The company reversed from a profit of 3 cents per share to a loss of 6 cents per share.

The company issued above-consensus revenue guidance for fiscal year 2021.

The stock jumped 16.67% to $45 in after-hours trading.

Pacira's Non-Opioid Post-Surgical Pain Drug Gets FDA Approval For Pediatric Population

Pacira BioSciences, Inc. PCRX said the FDA has approved a supplemental new drug application that seeks expansion of the Exparel label to include use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia.

With this approval, Exparel is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age 6, the company said.

The stock gained 2.12% to $71.76 in after-hours trading.

Zealand's Rescue Medication For Low Blood Glucose Levels Cleared By FDA

Zealand Pharma A/S ZEAL said the FDA has approved Zegalogue injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 6 and above. Zegalogue will be be available in both an auto injector and prefilled syringe.

The stock moved up 3.45% to $36 in after-hours trading.

Novo Nordisk Application For Diabetes Drug Label Expansion Rejected By FDA

Novo Nordisk A/S NVO said the FDA issued a refusal-to-file letter covering the label expansion application for once-weekly semaglutide 2mg for the treatment of type 2 diabetes that was filed on Jan. 20.

In the letter, FDA has requested additional information including data relating to a proposed new manufacturing site. Novo Nordisk said it believes the already completed clinical trial program will be sufficient for approval of the label expansion application.

Novo Nordisk said it expects to resubmit the application to FDA during the second quarter of 2021.

In after-hours trading, the stock was slipping 1.48% to $70.

Insmed Drug Gets Japanese Regulatory Nod For Bacterial Lung Infection

Insmed Incorporated INSM announced that Japan's Ministry of Health, Labour and Welfare has approved Arikayce for the treatment of patients with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex who did not sufficiently respond to prior treatment with a multidrug regimen. The launch of the drug in Japan is anticipated in mid-2021.

Evelo Announces Licensing Agreement with Saudi Arabia-based Abdul Jameel for Lead Inflammation Drug

Evelo Biosciences EVLO and Abdul Jameel Health announced that the companies have entered into a strategic collaboration to develop and commercialize Evelo's lead inflammation product candidate EDP1815 in the Middle East, Turkey and Africa.

Under the terms of the agreement, Evelo received an upfront payment and equity investment. Evelo will be responsible for the development and manufacturing of EDP1815, while Abdul Latif Jameel Health will be responsible for regulatory submissions and commercialization activities in the agreed-upon regions. Evelo and Abdul Latif Jameel Health will participate in a 50-50 profit share arrangement.

Offerings

Exagen Inc. XGN priced its underwritten public offering of 3.7 million shares at a price of $16.25 per share to raise gross proceeds of $60.1 million. All of the shares to be sold in the offering are to be sold by Exagen. The gross proceeds to Exagen from the offering are expected to be $60.1 million.

The stock fell 9.78% to $17.25 in after-hours trading.

Anixa Biosciences, Inc. ANIX said it has increased the size of the previously announced bought-out deal for selling 4.286 million shares at a public offering price of $5.25 per share. The offering is expected to close on or about March 25, subject to satisfaction of customary closing conditions.

In after-hours trading, the stock plunged 19.15% to $5.49.

Verrica Pharmaceuticals Inc. VRCA priced its underwritten public offering of 2.034 million shares of its common stock at a price of $14.75 per share. The gross proceeds from the offering to Verrica are expected to be approximately $30 million.

The stock was down 2.56% to $16 in after-hours trading.

On The Radar

Earnings

• scPharmaceuticals Inc. SCPH (before the market open)
• AC Immune SA ACIU (before the market open)
• IDEAYA Biosciences, Inc. IDYA (before the market open)
• aTyr Pharma, Inc. LIFE (after the market close)
• Bionano Genomics, Inc. BNGO (after the market close)
• Relmada Therapeutics, Inc. RLMD (after the market close)

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