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 on Jan. 7)
- Apellis Pharmaceuticals Inc (NASDAQ: APLS) (announced results of a Phase 3 trial of its pegcetacoplan, which showed that the asset was superior to Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)'s rival drug Soliris in treating paroxysmal nocturnal hemoglobinuria)
- BioNTech SE – ADR (NASDAQ: BNTX)
- Bio-Rad Laboratories, Inc. (NYSE: BIO)
- COLLPLANT BIOTE/S ADR (NASDAQ: CLGN)
- Dermira Inc (NASDAQ: DERM)
- DexCom, Inc. (NASDAQ: DXCM)
- Epizyme Inc (NASDAQ: EPZM)
- Esperion Therapeutics Inc (NASDAQ: ESPR)
- Galera Therapeutics Inc (NASDAQ: GRTX)
- Grifols SA - ADR ADR Class B (NASDAQ: GRFS)
- Inspire Medical Systems Inc (NYSE: INSP)
- Mesoblast limited (NASDAQ: MESO)
- NuVasive, Inc. (NASDAQ: NUVA)
- Orthopediatrics Corp (NASDAQ: KIDS)
- Oyster Point Pharma Inc (NASDAQ: OYST)
- PTC Therapeutics, Inc. (NASDAQ: PTCT)
- Soligenix, Inc. Common Stock (NASDAQ: SNGX)
- Syneos Health Inc (NASDAQ: SYNH)
- TG Therapeutics Inc common stock (NASDAQ: TGTX)
- Turning Point Therapeutics Inc (NASDAQ: TPTX)
- Varian Medical Systems, Inc. (NYSE: VAR)
- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
- Veru Inc (NASDAQ: VERU)
- Xenon Pharmaceuticals Inc (NASDAQ: XENE)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Jan. 7)
- Evelo Biosciences Inc (NASDAQ: EVLO)
- Evolus Inc (NASDAQ: EOLS)
- Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)
- Second Sight Medical (NASDAQ: EYES)
Stocks In Focus
Midatech's Cancer Found Effective In Subcutaneous Injection Formulation
Midatech Pharma PLC-ADR (NASDAQ: MTP) said its Study 102 that evaluated subcutaneous administration of its lead compound MTD201, an experimental carcinoid cancer and acromegaly drug, met its primary endpoints, confirming similar pharmacokinetics and bioavailability of octreotide for subcutaneous and intramuscular routes of administration.
"It confirmed both the subcutaneous dosing route for MTD201, as well as the potential for extended dosing intervals. These are key advantages for patients, physicians and payors, being the first therapy to offer this, and also gives Midatech a competitive advantage versus others as we move the product through to potential approval," said Craig Cook, CEO of Midatech.
Intra-Cellular Prices 10M Common Stock Offering At a Discount
Intra-Cellular Therapies Inc (NASDAQ: ITCI) said it has priced its previously-announced public offering of 10 million shares of its common stock at $29.50 per share, aiming to generate gross proceeds of $295 million.
The stock slipped 2.65% to $30.18 in after-hours trading.
Avanex Wins US Patent Supporting Lead Drug
Anavex Life Sciences Corp (NASDAQ: AVXL) announced the award of U.S. Patent No. 10,507,196 by the U.S. Patent and Trademark Office, with the patent supporting its lead drug candidate AVANEX2-73 for the treatment of neurodevelopmental disorders including Rett syndrome, and multiple sclerosis. This patent, according to the company, will remain in force at least until 2037.
Shares were rising 10.69% to $3.21 in pre-market trading Wednesday.
Applied Therapeutics Aces Pivotal Mid-Phase Study of Drug to Treat Inherited Galactose Processing Disorder
Applied Therapeutics Inc (NASDAQ: APLT) announced positive topline results from the pivotal Phase 2 portion of the ACTION-Galactosemia in adult Galactosemia patients.
The company noted that AT-007 treatment resulted in a statistically significant and robust reduction in plasma galactitol vs placebo in adult Galactosemia patients.
Applied Therapeutics said it will continue to study long-term safety in adult Galactosemia patients and will initiate a pediatric study in 2020. It also said it expects to file for regulatory approval in the second half of 2020.
Versatem In-licenses Chughai's Solid Tumor Drug
Verastem Inc (NASDAQ: VSTM) announced it signed a global licensing agreement with Chughai Pharma to in-license the latter's RAF/MEK inhibitor CH5126766, which is under development for treating KRAS mutant solid tumors. CH5126766 is currently being studied in combination with Verastem's FAK inhibitor defactinib in a Phase 1 study followed by expansion cohorts.
The agreement vests on Verastem the responsibility for developing and worldwide commercialization of CH5126766. Verastem will make an upfront payment of $3 million and also pay royalties to Chugai.
The stock was advancing 11.11% to $1.40 in pre-market trading.
Apellis to Offer 7M Worth of Shares
Apellis, which reported a positive late-stage clinical readout Tuesday, said it has commenced an underwritten public offering of 7 million shares of its common stock. All stocks are to be offered by the company.
The stock fell 4.85% to $36.85 in after-hours trading.
Collegium FY2020 Revenue Guidance In Line, To Be Profitable In 2020
Collegium Pharmaceutical Inc (NASDAQ: COLL) guided full-year 2020 Xtampza product revenues to $150 million to $160 million and Nucynta franchise product revenues to $170 million to $180 million.
The guidance translates to full-year 2020 revenues of $320 million to $340 million, surrounding the $328.95 million consensus estimate and representing an 8%-15% growth from the 2019 consensus revenue estimate of $296.23 million.
"Xtampza ER growth, as well as a commitment to leverage our existing cost structure, will drive Collegium to profitability in 2020," said Joe Ciaffoni, CEO of Collegium.
The stock rose 3.16% to $20.56 85 in after-hours trading.