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 Feb. 25)
- Apyx Medical Corp APYX
- Aslan Pharmaceuticals Ltd ASLN (announced an $18-million private placement)
- Bioatla Inc BCAB
- Dicerna Pharmaceuticals Inc DRNA
- Five Prime Therapeutics Inc FPRX
- Glaukos Corp GKOS
- Myriad Genetics, Inc. MYGN
- Organogenesis Holdings Inc ORGO
- Pacira Biosciences Inc PCRX (announced fourth-quarter results)
- Pandion Therapeutics Inc PAND - announced a deal to be bought by Merck & Co., Inc. MRK for $1.85 billion
- Pliant Therapeutics Inc PLRX
- Vanda Pharmaceuticals Inc. VNDA
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Feb. 25)
- Acutus Medical Inc AFIB
- Aptose Biosciences Inc APTO
- Bioventus Class A Ord Shs (Proposed) BVS
- Epizyme Inc EPZM
- Intercept Pharmaceuticals Inc ICPT (reacted to fourth-quarter results)
- Lucira Health Inc LHDX
- Opthea Spon American Depositary Receipts Representing 8 Ord Shs OPT
- Sensei Biotherapeutics Inc SNSE
- Virios Therapeutics LLC VIR
- Voyager Therapeutics Inc VYGR
Stocks In Focus
Tricida Receives Appeals Denied Letter From FDA Regarding Veverimer
Tricida Inc TCDA said it has received an appeal denied letter, or ADL, from the FDA's Office of New Drugs in response to a formal dispute resolution request submitted in December regarding its NDA for veverimer, which is being evaluated as a treatment option for metabolic acidosis in chronic kidney disease patients.
While focusing on the magnitude and durability of the serum bicarbonate change seen in the TRCA-301/TRCA-301E trial being reasonably likely to predict clinical benefit, the OND's decision also reflects other deficiencies identified in the complete response letter received in August.
Separately, the company reported a narrower loss for the fourth quarter.
The stock was down 26.63% premarket at $5.40.
Puma Biotech Terminates Agreement With Greater China Licensing Partner
Puma Biotechnology Inc PBYI said its Chinese partner CANbridge Pharmaceuticals agreed to terminate their 2018 license agreement, in which Puma granted CANbridge exclusive rights to develop and commercialize Nerlynx in Greater China. The two parties have also decided to settle their arbitration related to the license agreement.
Simultaneously, Puma has agreed with Pierre Fabre to amend the terms of a 2019 license agreement that grants Pierre Fabre exclusive rights for Nerlynx within Europe, Turkey, the Middle East and Africa, to also include Greater China.
Under the terms of the various agreements implementing this transaction among the three companies, Puma will receive an upfront payment of $50 million from Pierre Fabre in consideration for the amendment to the 2019 license agreement, and CANbridge will receive a one-time $20-million termination fee from Puma to return all rights to neratinib in Greater China back to Puma.
Puma has agreed to dismiss the arbitration demand it filed in July against CANbridge related to the parties' 2018 license agreement, and as part of the settlement, CANbridge has agreed to dismiss its counterclaims against Puma.
Separately, Puma reported a decline in its fourth-quarter revenue and a wider loss.
BioCryst Gets Positive Opinion From EMA Committee Regarding Approval For Orladeyo In Hereditary Angioedema
BioCryst Pharmaceuticals, Inc. BCRX said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the approval of Orladeyo for routine prevention of recurrent attacks of hereditary angioedema in adult and adolescent patients ages 12 years and older.
Incyte's Anal Cancer Drug Application Validated By EMA
Incyte Corporation INCY announced the validation of its marketing authorization application for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma, who have progressed on, or who are intolerant of, platinum-based chemotherapy.
The EMA validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.
Assembly Biosciences Declines To Pursue Study Of Vebicorvir In Chronic Suppressive Therapy
Assembly Biosciences Inc ASMB said it is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir as a chronic suppressive therapy to concentrate its R&D efforts on finite and curative HBV therapies.
The stock was down 4.16% to $5.30 in premarket trading Friday.
Silence Therapeutics Gets $2M Milestone Payment From Licensing Deal With Mallinckrodt
Silence Therapeutics ADR Representing 3 Ord Shs SLN will receive a $2-million milestone payment following the initiation of work on a third target being explored under its ongoing RNAi research collaboration with Mallinckrodt PLC MNKKQ for the treatment of complement pathway-mediated diseases.
Lilly Secures Deal to Supply US Government With Additional Doses of Antibody Cocktail Therapy For COVID-19
Eli Lilly And Co LLY said the U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab, 700 mg, and etesevimab, 1,400 mg, together.
Bamlanivimab and etesevimab together recently received emergency use authorization for the treatment of recently diagnosed mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Additionally, the NIH recently updated the COVID-19 Treatment Guidelines to recommend the use of bamlanivimab plus etesevimab for the treatment of outpatients with mild to moderate COVID-19 who are at high risk of clinical progression.
Related Link: The Week Ahead In Biotech: J&J Vaccine Adcom Meeting, Sarepta FDA Decision And Plenty Of Earnings
Glaukos Therapy To Treat Ocular Disorder Aces Late-Stage Study
Glaukos announced that U.S. Phase 3 pivotal trial results for its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, known as Epi-on, met the study's primary efficacy endpoint, demonstrating a statistically significant improvement in maximum corneal curvature at six months from baseline between the treated and placebo-controlled arms.
The company said data suggest Epi-on has the potential to provide the first non-invasive, bio-activated drug therapy alternative for keratoconus. The data will serve as the basis for NDA submission with the FDA in 2022, the company added.
Separately, the company announced better-than-expected third-quarter results and issued above-consensus sales growth guidance for the first quarter.
Bioventus Reaches $3.1M Settlement With DoJ Related To Exogen Device
The U.S. Department of Justice announced that Bioventus has agreed to pay the government $3.61 million to resolve allegations that the company violated the False Claims Act by submitting improperly completed certificates of medical necessity for medically unnecessary devices from Oct. 1, 2012 through Dec. 31, 2018.
The stock was down 3% to $12.60 premarket.
Earnings
Natera Inc's NTRA fourth-quarter revenues climbed 35.1% to $112.4 million. The net loss per share widened from 46 cents to 89 cents.
The stock was up 8.5% premarket at $118.
Dicerna Pharmaceuticals Inc DRNA reported full-year revenues of $164.3 million, up from $23.9 million in 2019. The net loss per share narrowed from $1.76 to $1.52. The results trailed expectations.
The stock was down 5.37% premarket to $26.79.
Endo International PLC's ENDP fourth-quarter revenues slipped 1% year-over-year to $760.22 million in 2020 and adjusted EPS fell from 80 cents to 75 cents, ahead of the 48 cents per share estimate.
The stock was down 5.48% premarket at $8.80.
GenMark Diagnostics, Inc GNMK said its fourth-quarter revenues climbed 84% to $50.1 million, with ePlex revenues at $45.4 million. The net loss per share narrowed from 17 cents to 5 cents, wider than the consensus loss estimate of 1 cent per share.
The company guided to 2021 revenues of $188 million to $198 million and gross margin to 44%-46%. Analysts estimate revenues of $182.47 million for the year.
The stock was down 6.81% premarket at $17.52.
Dynavax Technologies Corporation DVAX reported fourth-quarter revenues of $19.6 million in 2020, up from $10.57 million in 2019. The net loss per share narrowed from 44 cents to 14 cents, while analysts had estimated a loss of 24 cents per share.
The stock was up 9.68% premarket at $8.95.
Vir Biotechnology Inc's VIR revenues increased from $980,000 in the fourth quarter of 2019 to $1.734 million in the fourth quarter of 2020. The loss widened from 71 cents per share to 83 cents per share, while analysts estimated a loss of 70 cents per share.
The stock was down 2.51% premarket at $62.50.
Supernus Pharmaceuticals Inc SUPN said its fourth-quarter revenues climbed from $100.45 million in 2019 to $143.56 million in 2020, while the EPS fell from 62 cents to 57 cents. Analysts, on average, estimates EPS of 52 cents.
The company guided to 2021 revenues of $550 million to $580 million.
The stock slipped 8.32% to $27 premarket Friday.
Offerings
Edesa Biotech Inc EDSA said, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 1.5623 million common shares of Edesa, at a price to the public of $6.40 per share. The closing of the offering is expected to occur on or about March 2, subject to satisfaction of customary closing conditions.
The stock was down 9.98% premarket at $5.95.
On The Radar
Adcom Meeting
FDA's Vaccine & Related Biological Products Committee is scheduled to meet Friday, Feb. 26, between 9 a.m. and 5:30 pm, to discuss Johnson & Johnson JNJ unit Janssen's emergency use authorization application for its COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.
Clinical Readouts
Amgen, Inc. AMGN and AstraZeneca plc AZN will present at the American Academy of Allergy, Asthma & Immunology meeting, scheduled for 1 p.m., data from the Phase 3 NAVIGATOR study of tezepelumab in patients with severe asthma.
Earnings
- Amneal Pharmaceuticals Inc AMRX (before the market open)
- Orthofix Medical Inc OFIXP (before the market open)
- Recro Pharma Inc REPH (after the close)
Related Link: Attention Biotech Investors: Mark Your Calendar For February PDUFA Dates
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