The Daily Biotech Pulse: FDA Approves Karyopharm's Blood Cancer Treatment, Grifols' Immunodeficiency Drug; ESMO, ISTH Conferences In The Spotlight

The following is a roundup of the top developments in the biotech space over the last 24 hours. 

Scaling The Peaks

(Biotech stocks that hit 52-week highs July 3.)

• Abbott Laboratories ABT

• Apellis Pharmaceuticals Inc APLS

• Arena Pharmaceuticals, Inc. ARNA

• ArQule, Inc. ARQL

• BIO-TECHNE Corp TECH

• Coherus Biosciences Inc CHRS

• Eidos Therapeutics Inc EIDX

• Fate Therapeutics Inc FATE

• Merck & Co., Inc. MRK (Mizuho Securities initiated coverage of the stock with a Buy rating and $97 price target.)

• ResMed Inc. RMD

• GALAPAGOS NV/S ADR GLPG

• Illumina, Inc. ILMN

• Karuna Therapeutics Inc KRTX(IPOed June 28)

• Kodiak Sciences Inc KOD

• MeiraGTx Holdings PLC MGTX

• Mirati Therapeutics Inc MRTX

• Ra Pharmaceuticals Inc RARX

Down In The Dumps

(Biotech stocks that hit 52-week lows July 3.)

• Advaxis, Inc. ADXS

• BioNano Genomics Inc BNGO

• Gamida Cell Ltd GMDA

• Ideaya Biosciences Inc IDYA

• Kaleido Biosciences Inc KLDO

• Kezar Life Sciences Inc KZR

• OncoSec Medical Inc ONCS

• OpGen Inc OPGN

• Prevail Therapeutics Inc PRVL (The company went public June 20.)

See also: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

Stocks In Focus

KaryoPharm Secures Approval For Multiple Myeloma Drug Combo

Karyopharm Therapeutics Inc KPTI finally found favor with the FDA after overcoming initial hurdles. 

The FDA has approved its selinexor to be sold under the brand name Xpovio, in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, the company announced Wednesday after the close.

The company noted that continued approval hinges on the verification and description of clinical benefit in a confirmatory trial. It expects Xpovio to be available in the U.S. on or before July 10.

After surging over 36% in Wednesday's regular session in reaction to a website update on the approval ahead of the official communication from the FDA, the stock added 5.66% to $9.40 in after-hours trading.

FDA Greenlights Grifols’ Immunodeficiency Drug

GRIFOLS S A/S ADR GRFS announced FDA approval for Xembify, its new 20% subcutaneous immunoglobin, to treat primary immunodeficiencies. Xembify is a 20% immune globulin solution for subcutaneous injection indicated for treatment of primary humoral immunodeficiency in patients 2 years and older.

The company said it plans to launch the product in the U.S. in the last quarter of 2019. Grifols also said it is working with health care authorities to obtain approval in Canada, Europe and other markets.

Novartis' Sandoz Unit to Launch Generic Lung Cancer Drug

Novartis AG NVS's Sandoz generic unit announced the launch of the generic version of AstraZeneca plc AZN's gefitinib for adult patients with locally advanced or metastatic non-small cell lung cancer, or NSCLC, with activating mutations of EGFR-TK. 

Sandoz said the drug will be available immediately in 13 countries across Europe on the day the reference medicine loses market exclusivity.

Clinical Trial Readouts

• CELYAD SA/ADR CYAD will present at the ESMO 21st World Congress on Gastrointestinal Cancer conference Phase 1 data for its CYAD-1 and FOLFOX in colorectal cancer. The company will also present Phase 1 data from a study named alloSHRINK for CYAD-101 in colorectal cancer.

• Uniqure NV QURE is due to present at the 27th Congress of the International Society of Thrombosis and Haemostasis, or ISTH, with nine-month data from the Phase 2b study of AMT-061 in hemophilia B.

• Sangamo Therapeutics Inc SGMO is scheduled to present at the ISTH congress with initial Phase 1/2 data for SB-525 in hemophilia A.

• Catalyst Biosciences Inc CBIO is set to release final Phase 2 data for marzeptaacog alfa in hemophilia at the ISTH congress.

Related Link: FDA Places Unum's Early Stage Cancer Drug Trial On Clinical Hold