The following is a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech stocks that hit 52-week highs Feb. 13.)
- Anavex Life Sciences Corp AVXL
- AtriCure Inc. ATRC
- Beam Therapeutics Inc BEAM
- BioXcel Therapeutics Inc BTAI
- Brainstorm Cell Therapeutics Inc BCLI
- ChemoCentryx Inc CCXI
- Cytokinetics, Inc. CYTK
- DexCom, Inc. DXCM
- Dr.Reddy's Laboratories Ltd RDY
- Esperion Therapeutics Inc ESPR
- Fortress Biotech FBIO
- Insulet Corporation PODD
- Krystal Biotech Inc KRYS
- Masimo Corporation MASI
- NeoGenomics, Inc. NEO
- Nevro Corp NVRO
- Recro Pharma Inc REPH
- ResMed Inc. RMD
- Revolution Medicines Inc RVMD (went public Thursday)
- Syneos Health Inc SYNH
- Tandem Diabetes Care Inc TNDM
- Taro Pharmaceutical Industries Ltd. TARO
- West Pharmaceutical Services Inc. WST
- Xenon Pharmaceuticals Inc XENE
- Zai Lab Ltd ZLAB
- ZEALAND PHARMA/S ADR ZEAL
- Zoetis Inc ZTS(reacted to fourth-quarter results)
- Zimmer Biomet Holdings Inc ZBH
-
Down In The Dumps
- (Biotech stocks that hit 52-week lows Feb. 13.)
- ADDEX THERAPEUT/ADR ADXN
- Aptevo Therapeutics Inc APVO
- Bellerophon Therapeutics BLPH
- Brickell Biotech Inc BBI
- HTG Molecular Diagnostics Inc HTGM
- Precigen Inc PGEN
- Stealth BioTherapeutics Corp MITO
- Xeris Pharmaceuticals Inc XERS
See also: The Week Ahead In Biotech: SMID-Cap Earnings In The Spotlight
Stocks In Focus
Pulse Biosciences Dermatology Device Rejected By FDA; Company Plans $30M Rights Offering
Pulse Biosciences Inc PLSE said the FDA has issued a Not Substantially Equivalent letter that suggests the data provided does not show that the CellFX System is substantially equivalent to the predicate device.
This is in response to the company's 510(k) seeking clearance to commercialize the device, which is to be used in aesthetic dermatology.
The company also said its board has given the go-ahead for a rights offering to raise an additional $30 million in net proceeds.
The stock was down 29.8% at $8.55 in Friday's premarket session.
Sol-Gel's Skin Disease Drug Produces Positive Results
Sol-Gel Technologies Ltd SLGL announced positive topline data for its long-term safety study evaluating its Epsolay, or microencapsulated benzoyl peroxide cream, 5%, in papulopustular rosacea for a treatment duration up to 52 weeks.
The company said these results will complete the data required for finalizing the NDA submission. The NDA submission is planned for the second quarter of 2020, according to Sol-Gel.
The company also priced its underwritten public offering of 2.09 million shares together with ordinary share warrants to purchase 1.67 million shares at a combined public offering price of $11 per share and accompanying warrants.
The stock, which gained 10.07% to $15.41 in after-hours trading, was down 21.07% at $11.05 in Friday's premarket session.
Epizyme's Application For Tazverik Label Expansion Accepted For Priority Review
Epizyme Inc EPZM said the FDA accepted for priority review its sNDA for Tazverik, or tazemetostat, for patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.
The PDUFA action date is fixed for June 18, 2020. The drug was approved by the FDA to treat epithelioid sarcoma earlier this year.
Medigus Signs Deal Valued Up To $9M To Supply Equipment To Latin America
Medigus ADR MDGS announced the signing of a non-bounding MOU agreement with L-1 Systems for the licensing and sale of know-how and goods related to the Medigus Ultrasonic Surgical Endostapler system in the Latin American region. The contract is worth $4 million, with the potential for an additional $5 million for support services to be provided during the first year following the signing of a definitive agreement.
The stock was trading 9.58% higher to $1.83 in Friday's premarket session.
Assertio Completes Sale Of Collegium Pharma's Pain Franchise
Assertio Therapeutics Inc ASRT said it has closed its previously disclosed deal to sell its Nucynta franchise of products to Collegium Pharmaceutical Inc COLL for $375 million less royalties paid to Assertio in 2020.
Assertio shares were trading 4.44% higher to $1.41 at the time of publication Friday.
Eisai To Voluntarily Withdraw Weight Loss Drug Due To Cancer Risk
The FDA required Eisai Co., Ltd ESALY, the manufacturer of Belviq and Belviq XR, to voluntarily withdraw the weight-loss drug from the U.S. market following a safety clinical trial revealing an increased occurrence of cancer. In response, the company said it has submitted a request to voluntarily withdraw the drug.
J&J's Crohn's Disease Drug Shows Efficacy In Late-stage Trial
Johnson & Johnson JNJ's Janssen unit announced interim data from the Phase 3b STARDUST study that is evaluating Stellara in moderately to severely active Crohn's disease, showing 79% of patients achieving clinical response at week 16, and 67% in clinical remission. Intestinal ultrasound responses were detected as early as week four, the company said.
The data was presented as digital oral presentations at the 15th Congress of the European Crohn's & Colitis Organization.
Roche's Tecentriq Approved In China For Small Cell Lung Cancer
Roche Holdings AG Basel RHHBY said the China National Medical Products Administration has approved its Tecentriq in combination with chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer.
Earnings
DexCom, Inc. DXCM reported fourth-quarter revenue of $462.8 million, up 37% year-over-year. The non-GAAP income per share climbed from 56 cents to $1.15, exceeding the 74-cent-per-share consensus estimate. The company guided to 2020 revenue of $1.725 billion to $1.775 billion, in line with the Street estimate.
The shares were trading 8.64% higher to $274 at in Friday's premarket session.
Aytu Bioscience Inc's AYTU fiscal year second-quarter revenue climbed 77% to $3.2 million. The net loss per share narrowed from 72 cents to a penny. Analysts expected a loss of 24 cents per share on revenue of $2.74 million.
The stockwas jumpinh 13.17% to 86 cents in Friday's premarket session.
On The Radar
Clinical Readouts
Arena Pharmaceuticals, Inc. ARNA is due to present at the ECCO Congress Phase 2 open-label extension data for etrasimod in ulcerative colitis.
Adcom Meeting
FDA's Tobacco Products Scientific Advisory Committee is scheduled to meet to discuss the modified risk tobacco product applications submitted by 22nd Century Group Inc XXII for VLN King and VLN Menthol King combusted, filtered cigarettes. The company is pitching the tobacco products as "very low nicotine content" cigarettes.
Earnings
ImmunoGen, Inc. IMGN (before the market open)
Related Link: Attention Biotech Investors: Mark Your Calendar For These February PDUFA Dates
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