The Daily Biotech Pulse: Roche-Spark Deal Extended Again, Zymeworks' Positive Readout, Enanta Misses Earnings Estimate

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Nov. 21.)

• ACADIA Pharmaceuticals Inc. ACAD
• Alnylam Pharmaceuticals, Inc. ALNY
• Amgen, Inc. AMGN (raised full-year guidance following completion of Otezla purchase from Celgene)
• Antares Pharma Inc ATRS
• Arvinas Inc ARVN
• Axsome Therapeutics Inc AXSM
• Beigene Ltd BGNE
• BIO-TECHNE Corp TECH
• BridgeBio Pharma Inc BBIO
• Cue Biopharma Inc CUE
• Epizyme Inc EPZM
• Kamada Ltd. KMDA
• Kodiak Sciences Inc KOD
• Molecular Templates Inc MTEM
• Recro Pharma Inc REPH (completed spin-off of Baudax Bio in a bid to a become a pure play CDMO)

Down In The Dumps

(Biotech stocks that hit 52-week lows on Nov. 21.)

• AcelRx Pharmaceuticals Inc ACRX
• Aerie Pharmaceuticals Inc AERI (received European approval for its Rhokiinsa 0.02% for the reduction of elevated intraocular pressure)
• Affimed NV AFMD
• Anixa Biosciences Inc ANIX
• CareDx Inc CDNA
• Cumberland Pharmaceuticals, Inc. CPIX
• ENDRA Life Sciences Inc NDRA
• Genprex Inc GNPX
• Idera Pharmaceuticals Inc IDRA
• Interpace Biosciences Inc IDXG
• Invivo Therapeutics Holdings Corp NVIV (priced its previously announced common stock offering)
• Iterum Therapeutics PLC ITRM
• Jaguar Health Inc JAGX
• MacroGenics Inc MGNX
• Merrimack Pharmaceuticals Inc MACK
• Neon Therapeutics Inc NTGN (announced a changed focus and the elimination of 24% of workforce)
• Novavax, Inc. NVAX
• Nuvectra Corp NVTR
• Onconova Therapeutics Inc ONTX
• Sellas Life Sciences Group Inc SLS
• Sierra Oncology Inc SRRA
• Syros Pharmaceuticals Inc SYRS
• Tonix Pharmaceuticals Holding Corp TNXP (announced plans to commence Phase 2 proof-of-concept study of alcohol use disorder drug)
• Unum Therapeutics Inc UMRX
• Viveve Medical Inc VIVE

See also: Analyst: Peak Sales Potential Of Amarin's Vascepa Underappreciated

Stocks In Focus

Aslan Reports Publication Of Positive Pre-Clinical Data For Blood Cancer Drug

ASLAN PHARMACEU/ADR ASLN said new preclinical data for ASLAN003 as a potential treatment of acute myeloid leukemia has been published in the November issue of the Haematological Journal.

"The findings support ASLAN003's potential as a potent human dihydroorotate dehydrogenase (DHODH) inhibitor and novel target for differentiation therapy with a favourable toxicity profile," the company said.

Celyad Receives Funding From Belgium's Walloon Region

CELYAD SA/ADR CYAD said it has received 8.5 million euros ($9.3 million) in grants and non-dilutive funding from the Walloon Region of Belgium. The company said the funds will support the development of its CAR-T candidates, including CYAD-01 and CYAD-02 for the treatment of relapsed/refractory acute myeloid leukemia, as well as next-gen approaches in clinical development.

The stock was trading 11.06% higher at $12.65 in Friday's premarket session. 

Roche Extends Tender Offer To Buy Spark To Dec. 10

Roche Holdings AG Basel ADR RHHBY announced yet another extension in the offering period for its previously announced tender offer to buy all outstanding shares of Spark Therapeutics Inc ONCE for $114.50 per share.

The offer period has been extended from the earlier schedule of 5 p.m. on Monday, Nov. 25 until 5 p.m. Tuesday, Dec. 10.

The extension provides additional time for the U.S. FTC and U.K. Competition and Markets Authority to complete their previously disclosed review of the deal, the companies said. 

Zymeworks Reports Positive Phase 1 Readout For Solid Tumor Drug

Zymeworks Inc ZYME announced updated Phase 1 data for single agent ZW25 in heavily pretreated patients with HER-2 expressing solid tumors at the ESMO Asia Congress.

The disease control rate was 70%, comprising 44% partial responses and 26% stable disease, while 32% patients experienced disease control for greater than six months.

Out of the nine evaluable biliary duct cancer patients, the disease control rate was 78% and the objective response rate was 67%, while in the 13 colorectal cancer patients and 23 gastroesophageal adenocarcinoma patients, the overall response rates were 46% and 39%, respectively.

Along with its collaborator BeiGene, Zymeworks said it intends to advance ZW25 into potentially registration-enabling global studies in HER2-expressing biliary tract cancer and gastroesophageal adenocarcinoma.

Earnings

Enanta Pharmaceuticals Inc ENTA reported fourth-quarter revenue of $51.3 million versus $67.2 million in the year-ago period. The revenues comprised royalty revenue from worldwide net sales of AbbVie Inc ABBV's hepatitis C virus regimen Mavyret/Maviret. The net income per share declined from $1.30 to 44 cents. Analysts expected earnings per share of 53 cents per share.

The stock was down 5.84% at $59.80 in the premarket session. 

On The Radar

Clinical Trial Readouts

Society For Neuro-Oncology Presentations

VBI Vaccines Inc VBIV: Phase 1/2 data for VBI-1901 in recurrent glioblastoma multiforme. 

DelMar Pharmaceuticals Inc DMPI: Updated Phase 2 data for VAL-083 in unmethylated newly diagnosed glioblastoma multiforme as well as in unmethylated recurrent glioblastoma multiforme. 

strong>Agios Pharmaceuticals Inc AGIO: updated Phase 1 data for ivosidenib and vorasidenib in IDHm low-grade glioma. 

Related Link: The Week Ahead In Biotech: Clinical Readouts In Focus As Earnings Wind Down