The Daily Biotech Pulse: Lilly, Novartis Trail Q1 Estimates, Exec Departure At Applied Genetics, Patent Award For Scholar Rock, Aldeyra Data Readout

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 26)

• 10x Genomics, Inc. TXG
• Affimed N.V. AFMD
• Bio-Techne Corporation TECH
• Celcuity Inc. CELC
• Galectin Therapeutics Inc. GALT
• GW Pharmaceuticals plc GWPH
• Horizon Therapeutics Public Limited Company HZNP
• Ibere Pharmaceuticals IBER
• Insulet Corporation PODD
• Integra LifeSciences Holdings Corporation IART
• IRadimed Corporation IRMD
• Lantheus Holdings, Inc. LNTH
• Medpace Holdings, Inc. MEDP
• Merit Medical Systems, Inc. MMSI
• Natus Medical Incorporated NTUS
• NeuroPace, Inc. NPCE
• NovoCure Limited NVCR
• NuVasive, Inc. NUVA
• PLx Pharma Inc. PLXP
• Renalytix AI plc RNLX
• Seelos Therapeutics, Inc. SEEL
• ShockWave Medical, Inc. SWAV
• Treace Medical Concepts, Inc. TMCI (went public Friday)
• Vericel Corporation VCEL
• Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 26)

• Akoya Biosciences, Inc. AKYA
• Impel NeuroPharma, Inc. IMPL (went public Friday)
• Protara Therapeutics, Inc. TARA
• Rain Therapeutics Inc. RAIN (went public Friday)

Stocks In Focus

Applied Genetic Announces Departure Of Chief Scientific Officer

Applied Genetic Technologies Corporation AGTC said that Mark Shearman, its chief scientific officer, has resigned from the company to pursue another opportunity. Shearman will remain to facilitate a smooth transition through June 4, the company added.

The stock fell 5.31% to $4.10 in after-hours trading.

Sol-Gel Pulls Back; FDA Decision On Inflammatory Skin Condition Drug Remains Pending

Sol-Gel Technologies Ltd. SLGL shares came under pressure on no word from the company or the FDA regarding the new drug application for its Epsolay in the treatment of inflammatory lesions of rosacea by the PDUFA decision date.

The stock fell 9.39% to $12.45 in after-hours trading.

ObSeva Commences Long-Term Follow-Up Study Of Uterine Fibroid Drug

ObsEva SA OBSV said it has commenced the observational PRIMROSE 3 study that will evaluate long-term bone mineral density in subjects who completed at least 20 weeks of treatment in the Phase 3 PRIMROSE 1 in the U.S. and PRIMROSE 2 studies in Europe.

PRIMROSE 3 is a long-term follow-up study of PRIMROSE 1 and 2 patients across all dosing regimens of Yselty 100 mg or 200 mg daily, alone or with add-back therapy, as well as placebo recipients.

Novartis Misses Q1 Estimate

Novartis AG NVS reported first-quarter core EPS of $1.52 and net sales of $12.41 billion. These metrics missed the consensus estimates that called for EPS of $1.59 and revenues of $12.51 billion.

The stock was receding 0.16% to $87.67 in premarket trading Tuesday.

Related Link: The Week Ahead In Biotech (April 25-May 1): FDA Decisions For Sol-Gel, Protalix Bio, Ardelyx

Aldeyra's Reproxalap Aces Late-Stage Allergic Conjunctivitis Study

Aldeyra Therapeutics, Inc. ALDX announced positive top-line results from the Phase 3 INVIGORATE study of 0.25% reproxalap ophthalmic solution, an investigational new drug, in patients with allergic conjunctivitis. The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints, it added.

The stock was up 11.25% to $12.36 in premarket trading Tuesday.

Gilead Announces Scaled Up Remdesivir Availability In India

Gilead Sciences, Inc. GILD said it is providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient to rapidly scale up production of remdesivir in India.

The company said it will also donate at least 450,000 vials of remdesivir to help address the immediate needs of Indian patients.

"The recent surge of COVID-19 cases in India is having a devastating impact on communities and has created unprecedented pressure on health systems," said Johanna Mercier, chief commercial officer at Gilead Sciences.

Scholar Rock Announces Award Of Patent For Tech Used In Investigational Asset To Treat Spinal Muscular Dystrophy

Scholar Rock Holding Corporation SRRK said the U.S. patent office issued U.S. Patent No. 10,981,981, which broadly covers methods for making inhibitors of myostatin activation based on Scholar Rock's proprietary platform approach of targeting the precursor forms of growth factors.

The patent has an expiry of May 2034.

The issued claims are related to manufacturing methods for developing antibodies that bind selectively to pro/latent myostatin thereby inhibiting myostatin signaling.

Scholar Rock's apitegromab is a selective inhibitor of the activation of latent myostatin and is an investigational product candidate being developed towards an aim of improving motor function in patients with spinal muscular atrophy.

The stock was up 0.58% to $36.25 in after-hours trading.

On The Radar

PDUFA Dates

The FDA will rule on Protalix BioTherapeutics, Inc.'s PLX biologic license application for pegunigalsidase alfa in Fabry's disease.

Clinical Readouts

Cyclerion Therapeutics, Inc. CYCN will host a webinar at 8 am to provide a corporate update on clinical programs for its first-in-class CNS penetrant soluble guanylate cyclase stimulator, CY6463, in Alzheimer's disease with vascular pathology and mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes.

Earnings

Eli Lilly and Company LLY (Q1 non-GAAP EPS $1.87 Vs $2.14 consensus, Revenues $6.81 billion Vs. $7.02 billion consensus; FY21 Guidance updated to $7.80-$8 per share Vs. $8.32 consensus)

AtriCure, Inc. ATRC (after the close)

Amgen Inc. AMGN (after the close)

Illumina, Inc. ILMN (after the close)

IPOs

Protagenic Therapeutics, Inc. Common Stock PTIX priced an underwritten public offering of 3.18 million units at a public offering price of $4.15 per unit for aggregate gross proceeds of approximately $13.2 million.

Each unit is comprised of one share of common stock and one warrant to purchase one share of common stock. Each warrant is exercisable for one share of common stock at an exercise price of $4.98 per share and will expire five years from issuance.

In connection with the offering, the company has received approval to list its common stock and warrants on the Nasdaq Capital Market, with its common stock trading under the symbol PTIX and the warrants trading under the symbol PTIXW, with trading expected to begin Tuesday.

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