The Daily Biotech Pulse: Hyperphosphatemia Drug Regulatory Review Extended, Phathom Pharma Data Readout, 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 April 29)

• AtriCure, Inc. ATRC (announced Food and And Drug Administration approval of the EPi-Sense System to treat patients diagnosed with long-standing persistent Atrial fibrillation)
• Axonics, Inc. AXNX
• BioNTech SE BNTX
• Celldex Therapeutics, Inc. CLDX
• Dicerna Pharmaceuticals, Inc. DRNA
• Galectin Therapeutics Inc. GALT
• Harvard Bioscience, Inc. HBIO
• Ibere Pharmaceuticals IBER
• Insulet Corporation PODD
• IRadimed Corporation IRMD
• Lantheus Holdings, Inc. LNTH
• Madrigal Pharmaceuticals, Inc. MDGL
• Merit Medical Systems, Inc. MMSI
• NuVasive, Inc. NUVA
• PRA Health Sciences, Inc. PRAH
• ShockWave Medical, Inc. SWAV
• West Pharmaceutical Services, Inc. WST (announced its first-quarter results)
• Zimmer Biomet Holdings, Inc. ZBH

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 29)

• Adverum Biotechnologies, Inc. ADVM ( announced a serious adverse event in its gene therapy study)
• Aziyo Biologics, Inc. AZYO
• Cumberland Pharmaceuticals Inc. CPIX
• Dyadic International, Inc. DYAI
• Eloxx Pharmaceuticals, Inc. ELOX
• Lucira Health, Inc. LHDX
• OraSure Technologies, Inc. OSUR
• Protara Therapeutics, Inc. TARA
• Sigilon Therapeutics, Inc. SGTX

Stocks In Focus

Ardelyx Says Regulatory Review of Drug to Treat Elevated Blood Phosphate In Kidney Disease Patients Extended By 3 Months

Ardelyx, Inc. ARDX said the PDUFA goal date for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis has been extended by three months.

Following constructive labeling discussions with the FDA, the agency requested additional analyses to help the agency better understand the clinical data in light of tenapanor's novel mechanism of action as compared to approved therapies, the company said. The additional analyses submitted by the company constitute a major amendment to the new drug application, resulting in an extension of the PDUFA date by three months to July 29.

The stock declined 16.37% to $7.05 in after-hours trading.

Xeris' Glucagon Injection Gets U.K. Regulatory Nod

Xeris Pharmaceuticals, Inc. XERS said the U.K.'s Medicines and Healthcare Regulatory Agency has approved Ogluo (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

The company reiterated it is actively seeking a partner to commercialize Ogluo in the U.K., EU, and other regions, with a targeted fourth quarter launch in select EU countries.

The stock was up 5.43% to $4.08 in after-hours trading.

Phathom Pharma's Bacterial Infection Drug Aces Late-stage Study

Phathom Pharmaceuticals, Inc. PHAT said the PHALCON-HP, its pivotal Phase 3 clinical trial for the eradication of H. pylori infection, both vonoprazan-based regimens successfully met their primary endpoints and met all secondary endpoints.

The trial studied vonoprazan in combination with amoxicillin and clarithromycin and vonoprazan in combination with amoxicillin compared to lansoprazole in combination with amoxicillin and clarithromycin.

In the modified intent-to-treat population, H. pylori eradication rates were 84.7% with vonoprazan triple therapy and 78.5% for vonoprazan dual therapy compared to 78.8% with lansoprazole triple therapy, the company said.

The stock slipped 4.55% to $38 in after-hours trading.

Bristol-Myers Squibb Files sBLA For Opdivo For Treating Urothelial Carcinoma

Bristol Myers Squibb BMY announced that the FDA has accepted the supplemental biologics license application for Opdivo for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate -274 trial.

The FDA granted the application priority review and assigned a PDUFA goal date of Sept. 3.

Pfizer, BioNTech Seek Expansion of COVID-19 Vaccine Label to Include Adolescents In Europe

Pfizer, Inc. PFE and BioNTech said they have submitted a variation to the conditional marketing authorization in the European Union to the European Medicines Agency for the Comirnaty vaccine to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CMA will be valid in all 27 member states of the EU.

Alkermes Cedes a Board Seat to Sarissa Capital

Alkermes plc ALKS announced that it has reached an agreement with Sarissa Capital Management, a beneficial owner of approximately 5% of the company's outstanding ordinary shares, pursuant to which Sarissa Capital has the right to designate a director to the company's board.

Earnings

DexCom, Inc. DXCM said its first-quarter revenues climbed 25% year-over-year to $505 million but non-GAAP EPS fell from 44 cents in 2020 to 33 cents in 2021. Analysts, on average, estimated EPS of 30 cents per share. The company guided 2021 revenues to $2.26 billion to $2.36 billion, while the consensus estimate calls for revenues of $2.33 billion.

The stock fell 5.98% to $396.50 in after-hours trading.

Emergent BioSolutions Inc.'s EBS first-quarter revenues climbed 78% year-over-year to $343 million. Adjusted net income from share climbed from 1 cent per share in 2020 to $1.53 per share in 2021. The company lowered its 2021 forecast.

The stock slipped 5% to $59.99 in after-hours trading.

Gilead Sciences, Inc. GILD) reported first-quarter revenues of $6.4 billion, up 16% year-over-year. The non-GAAP EPS climbed 24% to $2.08, a penny below estimate. The company said it continues to expect total product sales of $23.7 billion to $25.1 billion, including $2 billion to $3 billion in Veklury sales, and non-GAAP EPS of $6.75-$7.45. The consensus estimates call for sales of $24.74 billion and non-GAAP EPS of $7.13.

In after-hours trading, the stock was down 1.61% to $62.81.

On The Radar

Earnings

AbbVie Inc. ABBV (before the market open)
Orthofix Medical Inc. OFIX (before the market open)
Alexion Pharmaceuticals, Inc. ALXN (before the market open)
Iradimed (before the market open)

IPOs

Vaccitech plc, a clinical-stage biopharma engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer, priced its initial public offering of 6.5 million ADSs, representing 6.5 million ordinary shares, at a price of $17 per ADS, for total gross proceeds of $110.5 million. All ADSs sold in the offering are being offered by Vaccitech. The ADSs are expected to begin trading on the Nasdaq under the ticker symbol VACC

Werewolf Therapeutics, Inc, a biopharma developing conditionally activated therapeutics engineered to stimulate the body's immune system for the treatment of cancer, priced its upsized IPO of 7.5 million shares of common stock at a price of $16 per share. The gross proceeds of the offering are expected to be approximately $120 million.

All of the shares are being offered by Werewolf. The shares are expected to begin trading on the Nasdaq under the ticker symbol HOWL.