The Daily Biotech Pulse: Japanese Cheer For AbbVie, Myokardia Offering, CytomX CFO Departs

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 March 25)

• Axsome Therapeutics Inc AXSM
• Catalyst Pharmaceuticals Inc CPRX
• CYCLERION THERA/SH CYCNV
• Veracyte Inc VCYT

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 25)

• Adamas Pharmaceuticals Inc ADMS
• Assembly Biosciences Inc ASMB
• Avadel Pharmaceuticals PLC AVDL
• Evogene Ltd EVGN
• Harpoon Therapeutics Inc HARP
• Proteostasis Therapeutics Inc PTI(reported disappointing Phase 1 results for its cystic fibrosis triplet therapy PTI-801, PTI-808 and PTI-428 and separate studies of PTI-801 and PTI 428 as add-on therapies to tezacaftor/ivacaftor)
• Unity Biotechnology Inc UBX
• Zafgen Inc ZFGN

Stock In Focus

AbbVie's Psoriasis Drug Approved In Japan

AbbVie Inc ABBV announced Japanese approval of its Skyrizi, an interleukin-23 inhibitor for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis, in adult patients who have an inadequate response to conventional therapies.

"This approval marks the first country approval in the world for SKYRIZI," AbbVie said.

PhaseBio Finalizes A New Term Loan Agreement

PhaseBio Pharmaceuticals Inc PHAS, which went public in late 2018, said it has secured up to $15 million in funds to support the clinical advancement of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, as well as for repaying its existing term loans in full.

The stock rallied 4.38 percent to $7.15 in after-hours trading.

Veracyte Presents New Findings Using Genomic Diagnostic Tool

Veracyte said it has presented new data from genomic diagnostic tool Affirma Xpression Atlas that suggested the majority of newly diagnosed medullary thyroid cancers, or MTC, are associated with variants from three genes. The findings were presented at the ENDO 2019, the Endocrine Society's annual meeting.

The stock rose 1.44 percent to $26.13 in after-hours trading.
See Also: More Pain For Recro Pharma: FDA Rejects Meloxicam NDA For Second Time

Celgene Makes Regulatory Filing For Multiple Myeloma Drug

Celgene Corporation CELG submitted a NDA to the FDA for its ozanimod for the treatment of adults with relapsing forms of multiple sclerosis. The submission was based on efficacy and safety data from the SUNBEAM and RADIANCE Part B Phase 3 trials.

""With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of RMS in 2020," Celgene said.

CorMedix To Begin Trading On Reverse Stock Split-adjusted Basis

CorMedix Inc. CRMD said its previously announced 1-for-5 reverse stock split of its common stock will take effect 9 a.m. ET Tuesday.

The stock gained 1.2 percent to $1.68 in after-hours trading.

CytomX CFO Departs

CytomX Therapeutics Inc CTMX announced the resignation of CFO Debanjan Ray, who is leaving to take up the position of CEO at a newly-formed private biotech company. CytomX said it is initiating a search for filling the role of CFO.

The stock slipped 1.64 percent to $10.5735 in after-hours trading.

Novartis' Sandoz Unit Announces Exclusive U.S. Launch of Generic Lung Blood Pressure Drug

Novartis AG NVS's Sandoz unit announced the U.S. availability of Treprostinil injection, which is indicated for treating pulmonary arterial hypertension. The product is the first fully substitutable AP-rated generic version of Remodulin, sold by United Therapeutics Corporation UTHR. Sandoz also said it has 180 days of marketing exclusivity for the product.

Offerings

Myokardia Inc MYOK announced it has commenced an underwritten public offering to sell $200 million shares of its common stock. All shares are to be sold by the company.

The company said it intends to use the net proceeds from the offering, along with its existing cash, cash equivalents and short-term and long-term investments, to support its pipeline development programs.

The stock slipped 3.59 percent to $50.01 in after-hours trading.

Zomedica Pharmaceuticals Corp ZOM priced its previously-announced underwritten public offering of 6.521 million common shares, at a price 46 cents per share. The company said it expects to receive gross proceeds of approximately $3 million from the offering. The offering is expected to close on or about March 28.

The shares fell 5.30 percent to 54 cents in after-hours trading.

On The Radar

Earnings

Onconova Therapeutics Inc ONTX (before the market open)
PhaseBio Pharma (after the market close)
Curis, Inc. CRIS (after the market close)