The Daily Biotech Pulse: Unity Biotech Licenses Anti-Aging Protein, Strong Results For Mereo's Brittle Bone Disease Drug

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 May 29)

• Chiasma Inc CHMA
• Soliton Inc SOLY(reacted to the news of the initiation of cellulite trial)
• Eidos Therapeutics Inc EIDX

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 29)

• Abeona Therapeutics Inc ABEO
• Adamis Pharmaceuticals Corp ADMP
• Adaptimmune Therapeutics PLC – ADR ADAP
• Akebia Therapeutics Inc AKBA
• Alkermes Plc ALKS
• Allena Pharmaceuticals Inc ALNA
• Allergan plc AGN
• AMAG Pharmaceuticals, Inc. AMAG
• Aptinyx Inc APTX
• Arbutus Biopharma Corp ABUS
• Axovant Gene Therapies Ltd AXGT
• BioCryst Pharmaceuticals, Inc. BCRX
• CAN-FITE BIOPHA/S ADR CANF(reacted to its first-quarter results and an update on clinical trial progress)
• Cidara Therapeutics Inc CDTX
• Diplomat Pharmacy Inc DPLO
• Eloxx Pharmaceuticals Inc ELOX
• Emergent Biosolutions Inc EBS
• Foamix Pharmaceuticals Ltd FOMX
• Hookipa Pharma Inc HOOK
• IMMURON LTD/S ADR IMRN
• Invivo Therapeutics Holdings Corp NVIV
• Melinta Therapeutics Inc MLNT
• Opko Health Inc. OPK
• Sellas Life Sciences Group Inc SLS
• Seres Therapeutics Inc MCRB
• Teva Pharmaceutical Industries Ltd TEVA(downgraded by UBS to Neutral on its legal woes)
• Theravance Biopharma Inc TBPH
• Xenetic Biosciences Inc XBIO

Stock In Focus

Unity Biotech In-Licenses Anti-Aging Molecule From UC San Francisco

Unity Biotechnology Inc UBX announced an exclusive, worldwide license agreement with the UC San Francisco regarding intellectual property relating to the alpha-klotho protein – a circulating factor associated with improved cognitive performance. Circulating levels of alpha-klotho protein gradually decline with age.

"We are exploring the utility of the alpha-Klotho protein in collaboration with world-renowned researchers from UCSF, with a goal to identify a potential drug candidate to treat particular diseases of aging, including cognitive decline," said Nathaniel David, President of Unity.

The company did not disclose the financial terms of the deal.

The stock rose 2.96 percent to $8.70 in after-hours trading.

Novartis Combo Asthma Treatment Aces Late-Stage Trial

Novartis AG NVS announced positive results for the Phase 3 trial dubbed PLATINUM, which assessed the safety and efficacy of QMF149 in treating inadequately controlled asthma.

QMF149 is a combination treatment of indacaterol acetate 150 Mu g, a long-acting beta agonist, and mometasone furoate 80 Mu g, an anti-inflammatory, which is being evaluated as a once-daily fixed dose combo treatment.

Novartis said once-daily low dose QMF149 met the primary and secondary endpoints of trough FEV1 and ACQ-7 score at Week 12, respectively when compared to once-daily mometasone furoate 200 Mu g, an ICS, delivered via the Twisthaler device, in both adult and adolescent patients with asthma.

Mesoblast Starts Rolling Submission for BLA For Drug to Treat Acute Graft Versus Host Disease

Australian biotech Mesoblast limited MESO, which develops cellular medicines for inflammatory diseases, said it filed the first component of the rolling submission for a BLA to the FDA for remestemcel-L in treating children with steroid-refractory acute graft versus host disease, or aGVHD – a life-threatening complication of an allogenic bone marrow transplant.

A rolling submission expedites the review process, as individual components can be submitted to the FDA and reviewed on an ongoing basis rather than waiting for all sections to be completed.

Mereo Brittle Bone Disease Drug Aces Mid-Stage Trial

MEREO BIOPHARMA/ADR MREO announced positive preliminary six-month data from the open-label arm of the Phase 2b study dubbed ASTEROID of BPS-804 in adults with Type 1, 3 or 4 osteogenesis imperfecta, or OI. The company said the data showed clear and encouraging percentage changes over baseline in trabecular volumetric bone mineral density measured at the radius.

The company expects to release topline 12-month data from the blinded arm of the study in the fourth quarter of 2019.

Zymeworks's Lead Asset Gets Fast Track Designation For Esophageal Cancer

Zymeworks Inc ZYME announced the FDA granted Fast Track designation to ZW25 for the first-line treatment of patients with HER2-overexpressing gastroesophageal adenocarcinoma in combination with standard of care chemotherapy. ZW25, a novel Azymetric bispecific antibody, is the company's lead asset.

The candidate is now being evaluated in Phase 1 and Phase 2 trials across North America and South Korea.

Stock Offerings

Amicus Therapeutics, Inc. FOLD has commenced a $150 million underwritten public offering of its common stock. The company expects to use the net proceeds for the development of the expanded gene therapy pipeline, among other things.

The stock fell 6.91 percent to $11.31 in after-hours trading.

Aptose Biosciences Inc APTO has commenced an underwritten public offering of its common shares. The company expects to use the net proceeds to accelerate and expand its clinical trial programs and for working capital and general corporate purposes.

The stock slumped 16.89 percent to $1.87 in after-hours trading.

On The Radar

Earnings

Ascendis Pharma A/S ASND (after the market close)