BPC June 17 update

Acadia ACAD (halted) 3-9 AdCom vote against approval; Biotech buyout rumors: MREO +63% AZN, CLVS +30% SNY

Price and Volume Movers

Due to the market being closed in observance of Juneteenth, BioPharmCatalyst will not be sending out our Pre-Market or Daily newsletters on Monday June 20, 2022.

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares were halted today after an FDA’s Advisory Committee ruled 9 to 3 that the evidence does not support the conclusion that NUPLAZID (pimavanserin) is effective for the treatment of hallucinations and delusions in the ADP population.

Mereo BioPharma Group plc (NASDAQ: MREO) shares closed up 63% at $1.3 after The Times reported that AstraZeneca (NASDAQ: AZN) may be considering a bid for the company. The speculative claims were made without attribution.

Sana Biotechnology Inc. (NASDAQ: SANA) shares closed up 21% at $5.15. following data reported showing survival of transplanted allogeneic, hypoimmune cells of several different types in a variety of locations in non-human primates.

Clovis Oncology (NASDAQ: CLVS) shares closed up 30% at $1.16 after online rumors were spread earlier this week regarding a supposide buyout by Sanofi (NYSE: SNY). No announcement regarding a possible acquisition has been made.

Atai Life Sciences (NASDAQ: ATAI) announced that the current Senior Vice President of Finance and Operations at BridgeBio Pharma (NASDAQ: BBIO) will be joining its company as chief financial officer. Atai shares closed up 4% at $3.24. BridgeBio shares closed up 18% at $7.65.

Scholar Rock (NASDAQ: SRRK) shares closed up 10% at $5.37 after it announced Phase 2 TOPAZ trial extension data of apitegromab to treat spinal muscular atrophy (SMA). Data noted that at 24 months the mean change from baseline in HFMSE reported a 4 point and 4.4 point change, for pooled non-ambulatory patients and excluding patients with scoliosis surgery respectively. Scholar Rock also announced a $205 million offering of stocks and warrants.

Advancers

CompanyPriceChange
OMER
Omeros Corporation
$1.01 +1.01  +100%
CLVS
Clovis Oncology Inc.
$1.01 +1.01  +100%
MREO
Mereo BioPharma Group plc
$1.01 +1.01  +100%
BLTE
Belite Bio Inc
$1.01 +1.01  +100%
INDP
Indaptus Therapeutics Inc.
$1.01 +1.01  +100%
TYRA
Tyra Biosciences Inc.
$1.01 +1.01  +100%
BLCM
Bellicum Pharmaceuticals Inc.
$1.01 +1.01  +100%
CRTX
Cortexyme Inc.
$1.01 +1.01  +100%
AUPH
Aurinia Pharmaceuticals Inc
$1.01 +1.01  +100%
ELYM
Eliem Therapeutics Inc
$1.01 +1.01  +100%

Decliners

CompanyPriceChange
TALS
Talaris Therapeutics Inc.
$1.01 -1.01  -100%
AKUS
Akouos Inc.
$1.01 -1.01  -100%
FEMY
Femasys Inc.
$1.01 -1.01  -100%
CLDX
Celldex Therapeutics Inc.
$1.01 -1.01  -100%
PRVB
Provention Bio Inc.
$1.01 -1.01  -100%
EPIX
ESSA Pharma Inc.
$1.01 -1.01  -100%
ADIL
Adial Pharmaceuticals Inc
$1.01 -1.01  -100%
CDAK
Codiak BioSciences Inc.
$1.01 -1.01  -100%
LABD
Direxion Daily S&P Biotech Bear 3X Shares
$1.01 -1.01  -100%
PPBT
Purple Biotech Ltd.
$1.01 -1.01  -100%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ABBV – AbbVie Inc.
SKYRIZI (risankizumab)
Crohn’s Disease

$153.80
+0.64  +0%
Approved Approved June 17, 2022.
$271.8 billion

AURA – Aura Biosciences Inc.
AU-011 (IVT administration)
Indeterminate lesions (ILs) and choroidal melanoma (CM)

$14.21
+0.04  +0%
Phase 1/2 Phase 1b/2 12-month safety and efficacy data noted a statistically significant reduction in the tumor growth rate, a 64% tumor control rate, and visual acuity preservation rate of 71%, noted November 15, 2021. Phase 1b/2 reported results from retrospective matched case control study, treatment achieved statistically significant vision preservation compared current standard of care, noted June 22, 2022.
$415.8 million

BMY – Bristol-Myers Squibb Company
Breyanzi (lisocabtagene maraleucel)
Large B-cell lymphoma (LBCL)

$76.84
-0.16  0%
Approved Approved June 24, 2022.
$163.6 billion

CAPR – Capricor Therapeutics Inc.
CAP-1002 - (HOPE-3)
Duchenne Muscular Dystrophy (DMD)

$3.68
+0.19  +5%
Phase 3 Phase 2 one-year data reported a difference of skeletal muscle function noted a 3.8 for HOPE-2 treatment differences, 2.3 for placebo and Placebo group off-treatment, noted June 27, 2022. Phase 3 enrollment ongoing.
$89.5 million

CLSD – Clearside Biomedical Inc.
AU-011
Uveal melanoma including choroidal melanoma

$1.47
0.00  0%
Phase 2 Phase 2 safety data reported that there have been no related SAE, dose limiting toxicities, or grade 3 adverse events observed during the trial and that dose administration may improve the therapeutic index and optimize treatment parameters, noted November 10, 2021. Pivotal trial planned to be initiated in 2H 2022.
$88.4 million

CYTK – Cytokinetics Incorporated
Omecamtiv mecarbil
Heart failure with reduced ejection fraction (HFrEF)

$41.00
+1.71  +4%
PDUFA PDUFA date extended by three months to February 28, 2023. Advisory committee planned for December 13, 2022.
$3.5 billion

PFE – Pfizer Inc.
MYFEMBREE (Relugolix)
Endometriosis-associated pain

$52.31
-0.12  0%
PDUFA Deficiencies were noted by the FDA in the review of the application, final decision has yet to be made, noted April 12, 2022. PDUFA date extended to August 6, 2022.
$293.5 billion

PFE – Pfizer Inc.
Comirnaty (BNT162b2)
COVID-19 vaccine

$52.31
-0.12  0%
Approved FDA approval announced August 23, 2021. EUA approval for children 4 years - 6 months, noted June 17, 2022.
$293.5 billion

SRRA – Sierra Oncology Inc.
Momelotinib - (MOMENTUM)
Myelofibrosis

$54.99
0.00  0%
NDA Filing NDA submitted to FDA, response expected on 60 days after submission, est. August 2022, noted June 17, 2022.
$1.3 billion

SRRK – Scholar Rock Holding Corporation
Apitegromab (SRK-015) - (TOPAZ)
Spinal muscular atrophy (SMA)

$5.33
-0.16  -3%
Phase 2 Phase 2 late-breaker data showed an increase in RULM in both non-ambulatory cohorts. Greater increases in HFMSE (non-ambulatory) and Revised Hammersmith Scale (ambulatory) scores were seen in patients who were not limited by scoliosis or joint contractures, noted September 23, 2021. 12-month Phase 2 data reported that motor function improvements were observed in the primary and secondary efficacy endpoints in all cohorts, noted March 2022. Phase 2 trial extension data demonstrated sizable and sustained improvement in HFMSE scores observed at 24 months, noted June 17, 2022.
$275.2 million

VYNE – VYNE Therapeutics Inc.
FMX114
Atopic Dermatitis

$0.44
+0.05  +12%
Phase 1/2 Phase 2a enrollment completed June 17, 2022. Phase 2a safety and efficacy results expected in 3Q 2022.
$25.3 million